Change in oxygen saturation to fraction of inspired oxygen concentration (S/F) ratio [ Time Frame: Change in S/F ratio from baseline to day 5 after the first treatment ] [ Designated as safety issue: No ]

Patients randomized to one of two intervention arms, will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) every 12 hours, for 5 days or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.

Placebo Comparator: Placebo

Normal saline, the quantity and appearance same as the intervention arm.

Drug: Placebo

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult patients (age > 18);

Admitted to the hospital through the emergency department (ED);

High risk of developing ARDS (Lung Injury Prediction Score-LIPS greater than or equal to four;

New chest radiograph performed on clinical grounds

Exclusion Criteria:

Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)

Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)

Previous enrollment in this trial.

Co-enrollment with LIPS-A trial is not allowed.

An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783821